Over time, Egaten, an antiparasitic, can increase the QTc interval, resulting in a heart rhythm condition that can cause chaotic heartbeats.
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Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.
Once approved, the insulins will be available to patients for no more than $30 per vial.
Vonjo is the first treatment first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.
The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.
FDA approved Legend Biotech’s chimeric antigen receptor T-cell (CAR-T) treatment, Carvykti (ciltacabtagene autoleucel; cilta- cel), to treat relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy.
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
Agency says evidence points to Evusheld being more effective against omicron variants if doses are doubled.
The new indication for reducing the risk of cardiovascular death and hospitalization for heart failure is expected to boost Jardiance’s sales further. Revenue for the drug jumped 38% in 2021 to reach nearly $432 million globally.
This guidance discusses that individuals 12 years and older can receive the second dose of the Pfizer-BioNTech vaccine 3-8 weeks after the first. Additionally, the interval for those 18 years and older for Moderna is 4-8 weeks.
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Sanofi and GSK today announce will try to get approval from the FDA and the European Medicines Agency (EMA) for their COVID-19 vaccine, entering a crowded market.
Pyrukynd, developed by Agios Pharmaceuticals, is a PK activator and the first in this drug class. The company is also awaiting approval by the European Medicines Agency, and a decision is expected by the end of 2022.
The FDA’s authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster shot.
The CDC released the first real world data February 15 in a Morbidity and Mortality Weekly Report (MMWR) that infants younger than 6 months were overall 61% less likely to be hospitalized from COVID-19 if their mothers were vaccinated during pregnancy through completion of a 2-dose primary mRNA COVID-19 vaccine series with either Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax).
Asundexian is an oral factor XIa inhibitor currently under phase 2 trials for potential secondary thrombosis prevention in patients with non-cardioembolic ischemic stroke, atrial fibrillation, or recent myocardial infarction.
The solution, available immediately to all large health plans, is meant to simplify care for patients with complex conditions.
The FDA is postponing its Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for February 15. Pfizer notified the agency about new data from its ongoing clinical trial.
Under the proposed rule, CMS would cover Aduhelm and other monoclonal antibodies for Alzheimer’s disease patients only if they are participating in approved clinical trials.
The oral formulation of the muscle relaxant was also approved as a treatment for spasticity associated with spinal cord injuries.
BioMatrix Specialty Pharmacy is now included as a preferred provider in AscellaHealth’s home infusion pharmacy network.
Patients who are immunocompromised are advised to get a three-dose series and then a fourth dose.
Drugs works by interfering with the classical complement pathway.
The Biosimilars Forum Board of Directors recently appointed Juliana M. Reed as its new executive director and Formulary Watch got the scoop from Reed first hand.
The agency said data from a trial testing the PI3 kinase inhibitor as a treatment for chronic lymphocytic leukemia prompted the concern.
FDA approved the first generic version of Restasis 0.05% eye drops to increase tear production in patients whose production is suppressed due to dry eye.
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